Liver CirrhosisNCT01598064
Probiotics for Liver Cirrhosis With Portal Hypertension
A study testing GK#10 in people with Liver Cirrhosis and Portal Hypertension, run by Po-Lin Chen, MD at 1 site in Taiwan.
Trial summary
Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension
- What is being tested?
- GK#10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis
- Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (< 100,000/ml)
Who cannot join
- Active infection
- Dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke
- Hepatocellular carcinoma with life expectancy < 6 months
- Portal vein thrombosis
- in hepatic encephalopathy or liver function ALT > 3 x UNL, T-bilirubin > 4.0 mg/dL
- GI tract bleeding in recent 1 weeks
- Drug abuser
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Probiotics in Preventing Complication Related to Portal Hypertension in Cirrhotic Patients
Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.
Read the detailed description
The investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. They will be given GK#10 or placebo for 8 weeks. Clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. Primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation.
The investigators anticipate providing our sponsor with useful results about GK#10. The investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. If the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Being tested
- GK#10, Placebo
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GK#10Dietary supplement
Also called Probiotics
GK#10, 1 pack tid
PlaceboDrug
Placebo 1 pack tid po
| Study group | Role | What they receive |
|---|---|---|
| GK#10 | Experimental | GK#10 1 pk tid for 8 weeks Receives: Dietary Supplement: GK#10 |
| Placebo | Placebo comparator | Placebo 1 pack tid for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission Due to Complications Related to Portal Hypertension
Measured: 8 weeks
Secondary outcomes (1)
Liver Function Evaluation
Measure ALT level of patients
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Po-Lin Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Sponsor-investigator, Po-Lin Chen, MD, National Cheng-Kung University Hospital
- Investigators
- Xi-Zhang Lin, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598064
- Sponsor's protocol ID
- GK#10
- Status last verified
- Jul 2014
- First submitted
- 8 May 2012
- Last updated
- 18 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Guerrero Hernandez I, Torre Delgadillo A, Vargas Vorackova F, Uribe M. Intestinal flora, probiotics, and cirrhosis. Ann Hepatol. 2008 Apr-Jun;7(2):120-4.
PubMed 18626428De Minicis S, Brenner DA. NOX in liver fibrosis. Arch Biochem Biophys. 2007 Jun 15;462(2):266-72. doi: 10.1016/j.abb.2007.04.016. Epub 2007 May 2.
PubMed 17531188Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available.
PubMed 7927273Johansson ML, Molin G, Jeppsson B, Nobaek S, Ahrne S, Bengmark S. Administration of different Lactobacillus strains in fermented oatmeal soup: in vivo colonization of human intestinal mucosa and effect on the indigenous flora. Appl Environ Microbiol. 1993 Jan;59(1):15-20. doi: 10.1128/aem.59.1.15-20.1993.
PubMed 8439146Salminen S, Salminen E. Lactulose, lactic acid bacteria, intestinal microecology and mucosal protection. Scand J Gastroenterol Suppl. 1997;222:45-8. doi: 10.1080/00365521.1997.11720717.
PubMed 9145446
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Probiotics in Preventing Complication Related to Portal Hypertension in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT01598064
- Acronym / sponsor ID
- GK#10
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Po-Lin Chen, MDUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.
Detailed description
The investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. They will be given GK#10 or placebo for 8 weeks. Clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. Primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation.
The investigators anticipate providing our sponsor with useful results about GK#10. The investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. If the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GK#10 | Experimental | Dietary Supplement: GK#10GK#10 1 pk tid for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 pack tid for 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis
- Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (< 100,000/ml)
Key exclusion criteria (8 listed)
- Active infection
- Dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke
- Hepatocellular carcinoma with life expectancy < 6 months
- Portal vein thrombosis
- in hepatic encephalopathy or liver function ALT > 3 x UNL, T-bilirubin > 4.0 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GK#10Also: ProbioticsGK#10, 1 pack tid | Dietary supplement | GK#10 |
| PlaceboPlacebo 1 pack tid po | Drug | Placebo |
Primary outcome
Admission Due to Complications Related to Portal Hypertension
Time frame: 8 weeks
1 secondary outcome
Liver Function Evaluation
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18626428Guerrero Hernandez I, Torre Delgadillo A, Vargas Vorackova F, Uribe M. Intestinal flora, probiotics, and cirrhosis. Ann Hepatol. 2008 Apr-Jun;7(2):120-4.
- Background: PubMed 17531188De Minicis S, Brenner DA. NOX in liver fibrosis. Arch Biochem Biophys. 2007 Jun 15;462(2):266-72. doi: 10.1016/j.abb.2007.04.016. Epub 2007 May 2.
- Background: PubMed 7927273Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available.
- Background: PubMed 8439146Johansson ML, Molin G, Jeppsson B, Nobaek S, Ahrne S, Bengmark S. Administration of different Lactobacillus strains in fermented oatmeal soup: in vivo colonization of human intestinal mucosa and effect on the indigenous flora. Appl Environ Microbiol. 1993 Jan;59(1):15-20. doi: 10.1128/aem.59.1.15-20.1993.
- Background: PubMed 9145446Salminen S, Salminen E. Lactulose, lactic acid bacteria, intestinal microecology and mucosal protection. Scand J Gastroenterol Suppl. 1997;222:45-8. doi: 10.1080/00365521.1997.11720717.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi-Zhang Lin principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GK#10 in people with Liver Cirrhosis and Portal Hypertension, run by Po-Lin Chen, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission Due to Complications Related to Portal Hypertension (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598064, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.